CaregiverNCT04129138
Patient and Caregiver Attitudes and Beliefs Regarding Prescription of Intranasal Naloxone Spray for Opioid Overdose
An observational study of Caregiver and Patient, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Survey Administration
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients prescribed naloxone in the last year and their caregivers.
Who may be able to join
- Patients must have been prescribed intranasal naloxone in the past 1 year
- Patients and caregivers must be able to understand, read, write, and speak English
- Patients must have no clinical evidence of cognitive impairment, as determined by the palliative care provider (Memorial Delirium Assessment Scale score of >= 7)
- Patients must sign an informed consent
- Caregivers may sign an informed consent if available during the visit
- Caregivers may verbally consent over the phone if not present during the visit
- Caregiver must be a friend, significant other or family member
- Caregivers must have no evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place
Who cannot join
- PATIENT: Emotional or psychosocial distress as identified by the patient's palliative care
- PATIENT: Participants with Edmonton Symptom Assessment System (ESAS) anxiety score of > 6
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Survey of High Risk Patient and Caregiver Attitudes and Beliefs Regarding the Prescription of Intranasal Naloxone Spray for Opioid Overdose
This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them.
SECONDARY OBJECTIVES:
- To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.
II. To determine the association between high risk patients' and their caregivers' characteristics (this includes cut-annoyed-guilty-eye [CAGE], screener and opioid assessment for patients with pain [SOAPP], age, gender, ethnicity, education, employment status, presence of caregiver, cancer type, cancer stage, reason for Narcan prescription, health insurance, and setting of Narcan prescription) and their perception that a prescription for intranasal naloxone is beneficial for patients.
EXPLORATORY OBJECTIVE:
- To conduct an exploratory analysis of high risk patients' and caregivers' attitudes and beliefs regarding prescription of intranasal naloxone spray.
OUTLINE:
Participants complete a survey over 30 minutes.
- Being tested
- Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Participants complete a survey over 30 minutes. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them
Measured: Up to 1 year
Secondary outcomes (2)
To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.
Measured: Up to 1 year
To determine the association between high risk patients' and their caregivers' characteristics
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start18 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jaya S Amaram-Davila, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129138
- Sponsor's protocol ID
- 2019-0330
- Other IDs
- NCI-2019-06740, 2019-0330
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2019
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of High Risk Patient and Caregiver Attitudes and Beliefs Regarding the Prescription of Intranasal Naloxone Spray for Opioid Overdose
- ClinicalTrials.gov ID
- NCT04129138
- Acronym / sponsor ID
- 2019-0330
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. Knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.
Detailed description
PRIMARY OBJECTIVE:
- To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them.
SECONDARY OBJECTIVES:
- To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.
II. To determine the association between high risk patients' and their caregivers' characteristics (this includes cut-annoyed-guilty-eye [CAGE], screener and opioid assessment for patients with pain [SOAPP], age, gender, ethnicity, education, employment status, presence of caregiver, cancer type, cancer stage, reason for Narcan prescription, health insurance, and setting of Narcan prescription) and their perception that a prescription for intranasal naloxone is beneficial for patients.
EXPLORATORY OBJECTIVE:
- To conduct an exploratory analysis of high risk patients' and caregivers' attitudes and beliefs regarding prescription of intranasal naloxone spray.
OUTLINE:
Participants complete a survey over 30 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationParticipants complete a survey over 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed naloxone in the last year and their caregivers.
Key inclusion criteria (8 listed)
- Patients must have been prescribed intranasal naloxone in the past 1 year
- Patients and caregivers must be able to understand, read, write, and speak English
- Patients must have no clinical evidence of cognitive impairment, as determined by the palliative care provider (Memorial Delirium Assessment Scale score of >= 7)
- Patients must sign an informed consent
- Caregivers may sign an informed consent if available during the visit
Key exclusion criteria (2 listed)
- PATIENT: Emotional or psychosocial distress as identified by the patient's palliative care
- PATIENT: Participants with Edmonton Symptom Assessment System (ESAS) anxiety score of > 6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey) |
Primary outcome
To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them
Time frame: Up to 1 year
2 secondary outcomes
To determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient.
Time frame: Up to 1 year
To determine the association between high risk patients' and their caregivers' characteristics
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaya S Amaram-Davila, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caregiver and Patient, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.